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上海市奉贤区正博路三一竹胜园A15栋厂房
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Xingdeke Taishida Pharmaceutical Technology (Shanghai) Co., Ltd
Small freeze-drying machine
NegotiableUpdate on 05/07
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Overview
A small freeze dryer is a reliable choice. The new requirements of the R&D center for freeze-drying machines are the feasibility and reliability of scaling up the freeze-drying process. FDA investigators believe that there is a lack of strict documentation guidance for the process of developing process formulas, clinical trials, and commercial production. Therefore, they emphasize that cGMP should be used as a quality control measure and implemented as a standard specification throughout the process from research and development to production.
Product Details
Small freeze-drying machine manufacturer
1. Product design features:
The design structure is compact, with all components integrated into the box and equipped with casters for easy movement. The vacuum, refrigeration system, and other necessary components are fully configured and connected to the public facilities before use.
2. Design concept of small freeze-drying machine product:
The product provides a solution for the R&D center to explore the freeze-drying process. L * a is equipped with various appropriate components, devices, and sensors to control temperature, pressure, and time, providing sufficient control for various processes and ensuring their repeatability.
Including plate heat exchangers and other high-quality components, we can ensure that our freeze dryer has a heating and cooling rate of 1 ℃/minute (the same as industrial freeze dryers).
Process optimization can be easily achieved through the valve between the sample chamber and the condenser. This valve is used for pressure rise testing and thermodynamic control, making it easy to optimize the freeze-drying process. This valve can also load and unload products directly without defrosting when the condenser is not fully loaded.
The refrigeration system can achieve a condenser temperature of -85 ℃ and a laminate temperature of -60 ℃. Only suitable for HFC environmentally friendly refrigerants, ensuring that the environment is not polluted and can be used for a long time.
3. Flexible applications:
By using a capping device, the spacing between the layers can be easily adjusted, suitable for bottles of various capacities, sizes, and types. In addition, there is an interface left on the side of the freeze-drying machine for connecting 6-port multi manifold, which can freeze open freeze-drying bottles of CN29/32.
4. Solutions provided for advanced research and development centers
Quality, outstanding craftsmanship
The sample chamber and layer board use the same structure and materials as the industrial freeze dryer. The manufacturing material is 316L stainless steel and all internal components are designed to be easy to clean. The condenser is also made of 316L stainless steel and equipped with an electric heating rapid defrosting device.
The sample chamber and condenser are both equipped with transparent acrylic doors for easy observation of the entire freeze-drying process.
5. Accurate control, uniform temperature
Sandwich style laminated board with thermal conductive silicone oil circulation channels inside. This structure enables precise temperature control of the product during in-situ pre freezing and sublimation heating stages. The top layer of heat radiation board is used to ensure that all samples on the board are uniformly heated.
Usually used for research and development purposesSmall freeze-drying machineThe vacuum sensor is installed on the vacuum channel to reflect the vacuum level inside the chamber. The L * a device has a vacuum sensor located inside the chamber, which directly reflects the actual vacuum level of the environment in which the sample is located. This allows for the amplification effect that can be obtained in pilot studies.
6. Control system
Based on PLC control
A user-friendly interface
Touch screen control system
L * a seriesSmall freeze-drying machineThe main feature is the use of PLC instead of the microprocessor used in traditional models of this type. All industrial freeze dryers use PLC systems. So using the same system in the pilot freeze-drying machine can maximize the reliability and repeatability of the process, while making the equipment comply with cGMP standards.
The control of freeze-drying process through human-machine interface (HMI) mainly includes:
1. Information display of main components of the system (valves, motors, indicators, etc.)
2. Alarm information reception
3. Display of parameters in the freeze-drying cycle process
4. Eliminate the possibility of misoperation
5. Protect the system by authorizing the operator
6. Development of freeze-drying process
7. Download information through USB interface
The user interface is a very prominent and easy to understand 6.5-inch color touchscreen display. Through this touch screen, various parameters of the freeze-drying process can be quickly inputted. Alternatively, as an option, the device can also be connected to different peripherals such as a chart recorder, printer, or PC. With the PC connected, you can use both the original operating interface and the Windows interface for direct control.
9. Lyologger data acquisition software collects charts, events, alarms, and historical records (ASCII code files) through serial ports
10. LoStar/Lab is a SCADA program software specifically designed for research and development. It can design, load and store process programs to record the freeze-drying process in real time, draw freeze-drying curves, generate reports, historical records, alarms, etc.
11. Compliant with 21CFR11 standard.
